A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, PHASE I/II, DOSE-RANGING STUDY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Influenza (the flu) is a common infection caused by several related viruses. It is responsible for 20,000-40,000 deaths each year in the United States. When a new strain of flu infects people, the infection can spread around the world quickly. This worldwide spread is called a pandemic. Several pandemics have occurred in the last 100 years. These pandemics caused infection and death in a high number of people. In 1918, nearly 40 million people died in a flu pandemic. Many deaths occur among the very old and the very young. Some of the new human flu viruses come from bird flu viruses. Recently, some strains of bird flu viruses have infected people in Asia. One of these flu strains is called A/H5N1. There is concern this new strain could cause a pandemic. Vaccines can prevent infection and disease. Vaccines work by causing the body to make proteins called antibodies that fight infection. Sometimes more than 1 dose of vaccine is needed so that the body will make enough antibodies to fight infection. Some vaccines have been developed to prevent infection with flu viruses. Flu vaccines protect against flu and the health problems it causes. These vaccines are made from parts of killed flu virus. These vaccines are given as a "shot" in the arm. The purpose of this research study, which is sponsored by the National Institutes of Allergy and Infectious Diseases (NIAID) is to test a killed flu vaccine for the prevention of the bird flu virus, A/H5N1. This vaccine is considered investigational (or experimental). It has never been tested in humans. There is a possibility there are risks that we cannot foresee right now. This vaccine was made the same way as "regular" flu vaccine that is currently given to people every year before flu season. The purpose of this study is to find out what strength of this vaccine is needed to produce protective levels of "bird flu" antibodies, which will help us decide the right dose for use in the future if it is needed. The study will also look at how the body reacts to different strengths of the new A/H5N1 flu vaccine.